Our Services
Medical Device, IVD, Cosmetic, PPE regulatory and quality Services from Patient Guard are industry leading.
Patient Guard has developed into one of the leading regulatory consultancies, trading since 2017.
An established regulatory and quality assurance consultancy providing a comprehensive, single-source solution for all your compliance requirements.
Our medical device, IVD, cosmetic, and PPE compliance frameworks are precisely tailored to align with your unique operational scale. We deliver clear, strategic direction and continuous guidance throughout the entire lifecycle—giving you complete peace of mind that your critical projects remain in safe, expert hands.
Medical Devices
Medical Device Consultancy
Strategic compliance support guiding medical device and IVD organizations through complex international frameworks. We provide professional assistance across product development, risk assessment, and regulatory submissions from concept to market access.
CE Marking Technical Files (EU MDR)
Expert creation and ongoing remediation of technical documentation required for EU CE marking. We systematically review clinical pathways and general safety criteria to align files with strict Notified Body standards.
UKCA Mark Technical Files
Prepare technical files built to satisfy structural expectations for Great Britain distribution. We configure labeling verification assets and risk records matching UK MDR 2002 rules.
FDA 510(k) Submissions
Clear guidance navigating US market clearings. We organize pre-market notifications, map equivalence performance parameters, and assemble clean technical dossiers for efficient FDA agency reviews.
FDA Pre-submissions
Reduce development timeline uncertainty by coordinating formal early alignment with the FDA. We handle Pre-Sub request generation to capture structured strategy feedback early.
Medical Device UK Responsible Person
Essential regulatory support for international manufacturers entering Great Britain. We manage your direct MHRA device registrations, securely maintain technical file documentation, and act as your dedicated post-Brexit legal liaison.
Medical Device EU Authorised Representative
Seamless access to European healthcare markets via our German operations footprint. We fulfill strict legal representation criteria under EU MDR/IVDR, coordinate regulatory submissions, and provide comprehensive EUDAMED account support.
Person Responsible for Regulatory Compliance (PRRC)
Fulfill your regulatory compliance obligations smoothly under EU MDR and IVDR frameworks. Our designated Person Responsible for Regulatory Compliance (PRRC) services establish, oversee, and validate robust quality and safety systems.
Clinical Evaluation
Rigorous clinical data synthesis and analysis designed to satisfy complex EU MDR guidelines. We handle the professional planning, drafting, and updates for Clinical Evaluation Plans (CEP) and Reports (CER) tracking product lifecycles.
Post Market Surveillance (PMS)
Establish proactive vigilance frameworks designed to monitor adverse device actions and gather ongoing safety metrics. We streamline field corrective actions, track safety reports, and satisfy periodic validation mandates effortlessly.
Post Market Clinical Follow-up (PMCF)
Proactive collection and analysis of real-world device safety information post-market launch. We draft strategic Post-Market Clinical Follow-up plans and reports that continuously confirm the risk-benefit profile of your products.
Biological Evaluation
Comprehensive biocompatibility strategy and safety testing reviews structured carefully in compliance with ISO 10993 standards. We build clean toxicological profile documentation to confidently prove consumer safety across lifecycle changes.
ISO 14971 Risk Management
Construct clear, lifecycle-mapped hazard assessments and risk management matrices. We keep files audit-ready, satisfying underlying safety metrics required across EU MDR, IVDR, and UK frameworks.
In Vitro Diagnostics (IVDs)
IVD CE Marking Technical Files (EU IVDR)
Professional creation and technical restructuring of key analytical and clinical data dossiers. We ensure your In Vitro Diagnostic validation profiles meet rigorous European Notified Body metrics.
IVD UKCA Mark Technical Files
Structured documentation support built for diagnostic assets aiming for Approved Body reviews. We align technical performance profiles to fulfill UK market-entry criteria smoothly.
IVD UK Responsible Person
Essential regulatory support for international diagnostic manufacturers entering Great Britain. We manage your direct MHRA asset registrations, securely maintain technical file documentation, and act as your localized legal liaison.
IVD EU Authorised Representative
Seamless access to European healthcare markets via our German operations footprint. We fulfill strict legal representation criteria under EU IVDR, coordinate regulatory submissions, and provide comprehensive EUDAMED account support.
Performance Evaluation (EU IVDR)
Build comprehensive analytical, scientific, and clinical performance records in strict alignment with IVDR frameworks. We draft clear Performance Evaluation Plans (PEP) and Reports (PER) to support CE marks.
Scientific Validation Reports (EU IVDR)
Expert literature mapping and diagnostic analytical profiles bridging the link between specific target analytes and medical situations. We secure clear technical documentation ensuring successful market entries.
Post Market Performance Follow-up (PMPF)
Proactive performance lifecycle collection frameworks verifying continued compliance parameters. We draft robust IVD post-launch follow-up pathways confirming consistent real-world scientific validity.
Post Market Surveillance for IVD Manufacturers
Continuous monitoring tracking underlying IVD device quality indices, safety metrics, and diagnostic field trends. We handle comprehensive PMS Plans, Reports, and complex periodic updates (PSUR).
Quality Assurance
ISO 13485 QMS Implementation
End-to-end guidance to construct a reliable Quality Management System tailored to your exact manufacturing footprint. From initial gap analyses and process validation to complete support during Stage 1 and Stage 2 certification audits.
ISO 13485 Internal Auditing Service
Rigorous, independent system audits targeted at finding potential non-conformities before external registrars flag them. Optimize your auditing schedule, refine system documentation, and ensure ongoing compliance metrics remain high.
ISO 9001 Implementation
Construct dynamic corporate Quality Management Systems optimized to run efficiently with low administrative friction. We guide you from basic gap analyses through to complete operational audit readiness.
ISO 9001 Internal Auditing Service
Independent process assessments that confirm company performance standards remain optimized. Protect critical quality badges, uncover hidden bottlenecks, and prepare operations to easily pass surveillance reviews.
ISO/IEC 27001 Implementation
Secure essential business operations with structured Information Security Management Systems (ISMS). We build practical data control matrices that safeguard client profiles and accelerate commercial sales cycles.
ISO/IEC 27001 Internal Auditing Service
Objective validation of critical information security frameworks. We run thorough cyber vulnerability reviews and outline actionable corrective paths to help your organization retain structural certification flags.
CFR 21 Part 820 QSR Implementation
Comprehensive layout configuration to construct high-grade manufacturing practices complying with FDA expectations. Build validation matrices, standard operating files, and reliable record systems for the USA market footprint.
CFR 21 Part 820 QSR Internal Auditing Service
System audits engineered to align your operational workflows with strict FDA Quality System Regulation criteria. We map out compliance gaps to verify your facility is fully prepared for random regulatory inspections.
Cosmetics Services
Cosmetic Product Safety Reports (CPSR)
Expert toxicological profiles checking raw material exposure safety before retail launch. We help manufacturers provide validated structural proof satisfying necessary safety assessments for broad distribution.
Cosmetics Product Information Files (PIF)
Compile and maintain rigorous technical dossiers keeping formulations completely secure yet accessible for audit inspection. We verify compliance data fields against European and UK Cosmetics Regulations.
UK Cosmetics Responsible Person
Legally required representation services for non-UK cosmetic manufacturers selling in Great Britain. We fully safeguard consumer safety metrics and oversee accurate item profiles on the official UK SCPN database.
EU Cosmetics Responsible Person
Legal representation services facilitating access to the single European market for international beauty brands. Ensure continuous framework compliance while managing critical product notifications on the central EU CPNP database.
PPE Services
UK PPE Authorised Representative
Dedicated legal representation for overseas PPE brands placing products onto the Great Britain market. We run thorough technical file inspections ensuring items satisfy localized UKCA compliance tracking.
EU PPE Responsible Person
Strategic European market-access support validating items against rigorous PPE Regulation (EU) 2016/425 requirements. We check CE declarations and keep documentation ready for rapid competent authority reviews.
